A request for development of a product will
come from sales or marketing. Development will
begin on the Product. A theoretical formulation
will be prepared by the assigned scientist.
Where necessary, quoting will be done on the
formulation to verify it is feasible and solidify
amounts and types of raw material to be used.
Raw materials that are new or have not been
characterized will require at least 3, preferably
5, separate lots of samples to be brought in
for characterization testing.Raw materials that
have not been characterized will be tested for
particle size, loose and bulk density, flodex
measurements, loss on drying, and visual character
(i.e crystalline needles, fine amorphous powder,
etc).
Pilot work will be performed on the formulation
to test and verify that it is robust and will
manufacture well. All development work will
be documented in the product notebook.
For granulation, a process will be developed
to meet customer expectations for particle size,
moisture, density, and compaction characteristics
if required.
For tablets, formulation work will be done
to produce a tablet which will meet customer
expectations for size, shape, friability, disintegration,
and appearance.
When development is satisfactory to the scientist,
a report will be generated detailing the work
performed, all test results, and proposed formulation
and specifications.
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